Kornimate/medical-research-clean huggingface dataset:
palace 3: efficacy and safety study of apremilast to treat active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion. apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

psoriatic arthritis (psa) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. the immunopathogenesis of psa, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. apremilast (cc-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (pde4) enzyme inhibition. therefore, apremilast has the potential to be effective in the treatment of psa.

Eligibility criteria:
inclusion criteria: * males or females, aged ≥ 18 years at time of consent. * have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration. * meet the classification criteria for psoriatic arthritis (caspar) criteria for psa at time of screening. * must have been inadequately treated by disease-modifying antirheumatic drugs (dmards) * may not have axial involvement alone * concurrent tx allowed with methotrexate, leflunomide, or sulfasalazine * have ≥ 3 swollen and ≥ 3 tender joints. * males \& females must use contraception * stable dose of nsaids, narcotics and low dose oral corticosteroids allowed. * have at least one ≥2 cm psoriasis lesion exclusion criteria: * pregnant or breast feeding. * history of allergy to any component of the investigational product hepatitis b surface antigen and/or hepatitis c antibody positive at screening. * therapeutic failure on \> 3 agents for psa or \> 1 biologic tumor necrosis factor (tnf) blocker

Keywords: psoriatic arthritis psoriasis arthritis inflammation skin condition inflammatory cells apremilast cc-10004 phosphodiesterase type 4
pediatric difficult intubation

Conditions: Intubation; Cardiac Arrest

Summary: endotracheal intubation (eti) is perceived as the optimal method of providing and maintaining a clear and secure airway. the 2010 european resuscitation council (erc) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (cpr). these guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression. the aim of the study was to compare time and success rates of the vividtrac video-laryngoscope and the miller laryngoscope for emergency intubation during simulated pediatric cpr.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * paramedic student exclusion criteria: * not meet the above criteria * wrist or low back diseases
cortical representation of hyperalgesia induced by nerve growth factor

Conditions: Non-inflammatory Neuropathic Pain; Healthy Subjects

Summary: intraepidermal injection of nerve growth factor results in a non-inflammatory hyperalgesia for thermal and mechanical stimuli. this hyperalgesia is similar to the pathological ailments of patients with neuropathic pain. the mechanisms of the cognitive modulation of pain and hyperalgesia are not yet understood in this group of patients. the investigators plan to use ngf injection as a model of non-inflammatory neuropathic pain in healthy subjects to investigate the underlying neuronal mechanisms of this hyperalgesia using functional magnetic resonance imaging and resting state network analysis.


Eligibility criteria:
inclusion criteria: * no acute or chronic disease * no acute or chronic pain * age: 18-60 years * male * no medication use exclusion criteria: * metallic parts in the body * claustrophobia * drug or substance abuse

Keywords: use of ngf injection as a model of non-inflammatory neuropathic pain in healthy subjects
pharmacokinetic bioequivalence study of nebcinal® 150mg/3ml administered by aeroneb® idehaler® versus tobi® 300mg/5ml administered by pari lc plus®

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a genetic disease characterized by mutations in cftr (cystic fibrosis transmembrane conductance regulator) gene. mortality and morbidity are mostly related to the respiratory affection which appears early in neonates. the constant improvement in symptomatic treatments and care strategies allowed cf patients' life expectancy to be increased over the last decades. vital prognostic is related to bronchopulmonary infections. 39% of cf patients under 18 years old and 70% of adult cf patients are chronically infected by pseudomonas aeruginosa. elevated concentrations of tobramycin in broncho secretions, about 1000 times the mic, is obtained by inhaled administration of tobramycin and is active against in vitro resistant pseudomonas aeruginosa. study hypotheses : regarding literature data and in vitro studies, the administration of nebcinal® 150mg/3ml administered twice a day by aeroneb® idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as tobi® 300mg/5ml administered twice a day by pari® lc plus® in children and adult patients with cf. primary objective : to compare plasma concentrations after inhalation of nebcinal® 150mg/3ml administered by aeroneb® idehaler pocket® and tobi® 300 mg/5ml administered by pari lc plus®


Eligibility criteria:
inclusion criteria: * adults and children aged 6 years old and more * male or female * patients with cystic fibrosis (positive sudoral test, cl \> 60 mmol/l) * followed in a crcm (cf care centre) * fev1 ≥40% * informed consent collected from adults or parents or legal guardians and children. * affiliation to the national health insurance program (sécurité sociale). exclusion criteria: * - renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl * recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization * acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by : cough increase, sputum increase, decrease in tolerance to effort, loss of weight, lack of appetite, deterioration of respiratory function, - medical history of intolerance, toxicity or allergy to tobramycine, hypersensitivity to aminoside

Keywords: cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma
parental consanguinity and family history of kidney disease in turkish kidney disease population

Conditions: Hereditary Diseases

Summary: inbreeding and consanguineous marriages are known to increase the risk of autosomal recessive disorders. the aim of this study was to examine the association between consanguinity and kidney diseases in the adult turkish population.

this was a national, cross-sectional study recruiting patients from nephrology out-patient clinics and dialysis units. all patients between 18 and 70 years of age who were on follow up in outpatient clinic and dialysis unit at the istanbul medical faculty from october 2009 to october 2015 were included in the study. all patients and healthy controls enrolled in this study gave informed consent to participate in the survey. they were all asked to answer a questionnaire including socio-demographic data, history of familial kidney disease and consanguineous marriage. additional information was obtained from their private physicians and medical files. to ensure reliability of administration of the questionnaire, all interviewers underwent training using a standardized protocol.

Eligibility criteria:
inclusion criteria: * follow up in outpatient clinic and dialysis unit at the istanbul medical faculty * between 18-70 years old * provide informed consent exclusion criteria: * follow-up shorter than 6 months * patients whose data were not available * patients who were unwilling or unable to provide informed consent

Keywords: consanguinity-associated kidney diseases turkey population
a safety and efficacy study of bimatoprost 0.01% in primary open-angle glaucoma (poag) or ocular hypertension (oh)

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (iop) due to primary open-angle glaucoma (poag) or ocular hypertension (oh).


Eligibility criteria:
inclusion criteria: * elevated iop due to either primary open-angle glaucoma or ocular hypertension exclusion criteria: * none
anxiety in parkinson's: use of quantitative methods to guide rational treatment

Conditions: Anxiety Disorders; Parkinson Disease

Summary: this study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with parkinson's disease.

anxiety is a serious medical condition that worsens quality of life by negatively affecting peoples thoughts, feelings, and ability to function normally. anxiety can affect anyone, but people with parkinson's appear to be at a much higher risk with an estimated 40% or more suffering from anxiety. parkinson's is a neurological disorder that causes tremor and other problems with normal movements. the disease symptoms are believed to be caused in large part by the loss of dopamine producing cells in the midbrain. anxiety in parkinson's may be associated with the loss of dopamine caused by the disease and therefore may respond to dopamine based treatments. this study will evaluate the effectiveness of the rotigotine transdermal patch, a dopamine replacement medication, in reducing symptoms of anxiety in people with parkinson's disease. participants in this double-blind study will be randomly assigned to receive either rotigotine or a placebo patch for 8-weeks. all participants will be evaluated at the study site at baseline and weeks 2, 4, and 8. psychiatric, cognitive, and movement assessments will be performed along with a review of anxiety symptoms. all participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of diagnostic and statistical manual of mental disorders (dsm) 5 anxiety disorder * stable medical history and general health * on stable anti-parkinsonian therapy for 2 weeks before enrollment exclusion criteria: * unstable medical disease of comorbid psychiatric disease * dementia * subjects with less than one year duration of parkinson's * current treatment with a dopamine agonist

Keywords: anxiety disorders parkinson disease rotigotine
parents' differential susceptibility to microtrial

Conditions: Parenting; Child Behavior; Parent-Child Relations

Summary: this randomized controlled microtrial, not just focus on parental (and child) responsiveness but also on an underlying physiological mechanism hypothesized to contribute to heightened susceptibility to parenting interventions.

after being informed about the study, all participants giving written informed consent will be randomly assigned to the "micro" intervention condition (i.e., immediate positive parenting feedback) or care-as-usual control condition in a singe-blind manner in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * parents with children aged 4-5 years. exclusion criteria: * psychiatric/neurological disorder (as reported by the parent) * mental retardation (iq \< 70) * not mastering the dutch language, and * that their child is not living in another household during the weekdays

Keywords: differential susceptibility parenting intervention efficacy randomized controlled microtrial
journey ii vs persona knee systems - rct

Conditions: Knee Osteoarthritis

Summary: this study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either zimmer biomet persona posterior stabilized (ps) system and smith\&nephew journey ii bi-cruciate stabilized (bcs) system

the aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either zimmer biomet persona posterior stabilized (ps) system and smith\&nephew journey ii bi-cruciate stabilized (bcs) system. to this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \[1:1\]. all participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career. before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, womac and koos scales. 1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement

Eligibility criteria:
inclusion criteria: * listed for a primary total knee replacement (tkr) at the orthopaedic and rehabilitation department medical university of warsaw * indication for the tkr is primary osteoarthritis of the knee joint involving one or more compartments * aged 18 or over * patient willing to provide full informed consent to the trial exclusion criteria: * listed for a single-stage bilateral tkr procedure * severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure * fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur * clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater * any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety * inflammatory arthritis * previous septic arthritis in the affected knee joint * previous surgery to the collateral ligaments of the affected knee * patients on warfarin or novel oral anticoagulants (noacs) * will not be resident in the catchment area for at least 6 months post-surgery * undertaking the surgery as a private patient * patients who, in the opinion of the clinical staff, do not have capacity to consent * patients who are pregnant * unable to understand written and spoken polish
prognostic value of cd4/cd8 ratio in patients with nasopharyngeal carcinoma

Conditions: Histopathological Diagnosis of Nasopharyngeal Carcinoma; Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition

Summary: in our previous retrospective study, we identified circulating immune cell counts and the cd4/cd8 ratio as significant prognostic markers in nasopharyngeal carcinoma. building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte cd4/cd8 ratio in nasopharyngeal carcinoma patients prior to treatment.


Eligibility criteria:
inclusion criteria: * 1.histopathological diagnosis of nasopharyngeal carcinoma;2.patients with nasopharyngeal carcinoma without distant metastases after ajcc/uacc 8th edition;3.the radiation therapy technique is imrt;4.age 18-70 years;5.has good organ function;6.patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies. exclusion criteria: * 1.concomitant with other tumors;2.those with a history of severe immediate allergies to any of the drugs used in this study;3.lack of or limited capacity for civil conduct;4.addiction to drugs or alcohol, with a physical or psychiatric disorder;5.previous diagnosis of immunodeficiency or known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related disease;6.pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.

Keywords: nasopharyngeal carcinoma peripheral blood circulating lymphocytes before treatment cd4/cd8 ratio prognostic value
watchman flx left atrial appendage closure device post approval study ( europe only)

Conditions: Non-valvular Atrial Fibrillation

Summary: watchman flx left atrial appendage closure device post approval study

watchman flx is intended to prevent thrombus embolization from the left atrial appendage and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or who have a contraindication to anticoagulation therapy.

Eligibility criteria:
inclusion criteria: 1. subjects who are eligible for a watchman flx device according to current international and local guidelines and currently approved indications; 2. subject who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre; 3. subjects whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. exclusion criteria: 1. subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. each instance should be brought to the attention of the sponsor to determine eligibility 2. the subject is unable or not willing to complete follow-up visits and examinations for the duration of the study 3. women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); 4. documented life expectancy of less than 12 months.
pressures during prone positions in healthy volunteers

Conditions: Pressure Ulcer

Summary: prone positioning (pp) reduces mortality in the most severe cases of acute respiratory distress syndrome (ards). despite the benefits of pp, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours. there are 2 pp techniques: 1. positioning with arms alongside the body 2. swimmer's position at present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care. pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. the investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a pc, provides a live display of the pressures between the patient and the mattress. the investigators would like to use their device to measure pressures during these 2 pp in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during pp.


Eligibility criteria:
inclusion criteria: * male or female * major volunteer exclusion criteria: * volunteers with cervical mobility problems preventing them from rotating their head 90° * volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction. * pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test). * volunteer not affiliated to a french social security system * volunteer protected by law

Keywords: healthy volunteer pressure mapping ards prone position
tricaprilin infantile spasms pilot study

Conditions: Infantile Spasm

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of tricaprilin in subjects with infantile spasms. this is a single-arm, open-label, pilot study in up to 10 subjects with infantile spasms. upon completion of the main phase, subjects who exhibit improvement in seizure control and who tolerate the compound will be offered continued use of the imp until benefit-risk ratio is no longer favourable, in a one-year open-label extension phase, available to australian participants only.


Eligibility criteria:
inclusion criteria: 1. male and female infants ages 3 months to 24 months, inclusive, at the time of parent/legal guardian signing the informed consent 2. clinical diagnosis of is, confirmed by analysis of a 24-hour video-electroencephalogram (veeg) recording, including at least one documented spasm 3. continued infantile spasms despite adequate treatment with oral prednisolone (or adrenocorticotropic hormone \[acth\]) and vigabatrin 4. if being treated with concomitant asds (other than ketogenic therapies/diet), current asds have been at a constant daily dose for at least 1 week. 5. subject is taking no more than 3 concomitant asds exclusion criteria: 1. subject considered by the investigator, for any reason, to be an unsuitable candidate to receive the investigational product 2. significant and active pre-existing cardiovascular, renal, liver, infectious, or other systemic disease 3. subject has clinically significant renal impairment 4. clinically significant abnormality on ecg that, in the opinion of the investigator, increases the safety risks of participating in the study 5. known or suspected allergy to the investigational product 6. known history of aspiration pneumonia within the past year 7. previous participation in another clinical study of the investigational product or received any investigational drug, device, or therapy within 30 days of study entry or within five half-lives of another investigational drug 8. within 14 days of screening, subject has: 1. received therapy with felbamate, cannabinoids, ketogenic diet, or vagus nerve stimulation 2. received therapy with acth, prednisolone or other steroid 9. pre-existing lethal or potentially lethal condition other than infantile spasms 10. previous failure to respond to an appropriate trial (at least 2 weeks) of the ketogenic diet